The New EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH 2B(R3) format: hands-on training course

Details

Title

The New EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH 2B(R3) format: hands-on training course

Date

26/02/2018
- 28/02/2018

Location

Bucharest, Romania

Summary

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.